Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Institute of Environmental Health Sciences (NIEHS)
Fogarty International Center (FIC)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Research on Women’s Health (ORWH)

The NIH announces an opportunity to request an
administrative supplement to NIH-funded research and training that would
support research into the health impacts of household air pollution (HAP)
from the incomplete combustion of biomass or solid fuels used for cooking,
heating or lighting. The purpose of this administrative supplement is
to provide opportunities for teams with current programs in lower and middle
income countries (LMIC) to conduct research or research training on the
relationship between exposure to HAP and the risk for adverse health effects
to women and children including but not limited to risks for asthma,
cardiovascular diseases, cancer, infections, ocular diseases, burns and
scalds, pregnancy outcomes, acute lower respiratory tract infection (ALRI) or
impaired growth and development in infants and children, and social and
behavioral aspects of stove adoption and reduction in HAP exposures.

Key Dates

Posted Date

June 11, 2012

Open Date (Earliest Submission Date)

June 11 2012

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

July 16, 2012, by 5:00 PM local time of applicant
organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Not Applicable

Advisory Council Review

Not Applicable

Earliest Start Date(s)

September 1, 2012

Expiration Date

July 17, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the Application Guide (SF 424
(R&R) Application Guide or PHS398
Application Guide, as appropriate) except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all
application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the
Application Guide, follow the program-specific instructions. Applications that
do not comply with these instructions may be delayed or not accepted for review.

The NIH announces an opportunity to request an
administrative supplement to NIH-funded research and training that would
support research into the health impacts of household air pollution (HAP) from
the incomplete combustion of biomass or solid fuels used for cooking, heating
or lighting. The purpose of this administrative supplement is to provide
opportunities for teams with current programs in lower and middle income
countries (LMIC) to conduct research or research training on the relationship
between exposure to HAP and the risk for adverse health effects to women and
children including but not limited to risks for asthma, cardiovascular
diseases, cancer, infections, ocular diseases, burns and scalds, pregnancy
outcomes, acute lower respiratory tract infection (ALRI) or impaired growth and
development in infants and children, and social and behavioral aspects of stove
adoption and reduction in HAP exposures.

Research Opportunity

The goal of this program is to provide administrative
supplements to currently funded NIH investigators interested in understanding
and preventing the adverse health outcomes of HAP to women and
children. This research opportunity is timely as a result of the recent
formation of the Global Alliance for Clean Cookstoves, a public-private
partnership within the United Nations Foundation that is promoting the global
distribution of more advanced cookstoves to improve health (http://cleancookstoves.org).

This program augments the NIH commitment to the Global
Alliance and to its mission to use advanced stoves and fuels to reduce HAP and
to improve human health, by providing administrative supplements to existing
NIH grants relevant to this topic. Eligible parent grants should include
studies in LMIC where HAP exists in urban or rural settings but the original
research or research training focus can be diverse. Examples of such parent
grants may include studies of adverse pregnancy outcomes, women’s or children’s
health, cardiovascular diseases, cancer, ALRI and other respiratory diseases,
ocular disorders or household-related burns or scalds; health impacts of
outdoor air pollution or environmental tobacco smoke; birth cohorts studying
prevalence of disease or interventions; social and behavioral studies of
health-related household activities such as water or sanitation practices;
application of evaluation methods that can assess health impacts in large
non-randomized cookstove implementation programs; field application of novel
technology such as personal exposure monitors or biomarkers relevant to the
purpose of the supplement; studies of children at risk for disease in early
life (asthma, child development including impaired learning or cognition,
malaria, tuberculosis, HIV/AIDS etc) as well as other diseases or conditions
related to pregnancy or early life risks.

Examples of research skills, experience and priorities that
would be responsive to this announcement include but are not limited to:

Demonstrating existing research experience in the developing
country setting with strong preference for in-country research partners
including investigators (one of whom may be co-principal investigator) and
familiarity with community engagement in conduct of research of health outcomes
in such settings, and particularly impact of HAP or related exposures;

Providing detailed information on how exposures will be assessed;
if novel exposure technologies to be used, the application should include
strategies for validation of these technologies for accuracy and
reproducibility in field use with assessment of HAP exposure levels;

Providing a rationale for the measures of selected health
outcomes;

Providing a plan to evaluate the possible impact of potential
confounders/effect modifiers including but not limited to other
combustion-sources of pollution, access to or utilization of health care,
nutritional status, and socio-economic status;

If an intervention is proposed, addressing critical issues such
as how to measure successful adoption of new technology such as advanced stoves
or fuels, any proposed training in use of new technologies or social/behavioral
changes needed to minimize exposures;

If use of biomarkers is proposed, demonstrating the relationship
between measured biomarkers and exposure and/or health outcomes;

Providing a plan for research training that would build capacity
to conduct studies such as those mentioned above.

The research or research training proposed by the NIH
grantee in the supplement application must be within the original scope of the
NIH-supported grant project. The funding mechanism being used to support
this program, administrative supplements, can be used to cover cost increases
that are associated with achieving certain new research objectives as long as
they are within the original scope of the project. Any cost increases
need to result from making modifications to the project in order to take
advantage of opportunities that would increase the value of the project
consistent with its originally approved objectives and purposes.

Section II. Award Information

Funding Instrument

The funding instrument will be the same as the parent
award.

Grant or Cooperative Agreement

Application Types Allowed

Non-competing Administrative Supplements

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH
appropriations, and the submission of a sufficient number of meritorious
applications.

Award Budget

NIH participating ICs intend to commit up to $1.2M in
FY2012 to fund up to 8 to 10 awards. Requested amounts must reflect
actual needs of the proposed project.

An applicant must request a project period of 1 year only.
The budget requests may be for $50,000 to $200,000 total costs (i.e., DC
+_F&A).

The budget can include salary support in addition to other
justified expenses, such as travel and supplies, for the proposed research or
research training recognizing that the research site is likely in a
developing country. The requested salary and fringe benefits must be in
accordance with the salary structure of the grantee institution for
individuals in comparable positions, consistent with the level of
effort.

Applicants are strongly encouraged to include travel
support for an investigator from their research team to attend the NIH
Training Course on Health Impacts of Household Air Pollution scheduled for October
10-12, 2012 on the NIH campus.

An award issued under this FOA is contingent upon adequate progress on the
parent grant during the current project period, the availability of funds,
and the receipt of a sufficient number of meritorious applications.

Although the financial plans of the NIH provide support
for this program, administrative supplement awards pursuant to this
initiative are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious requests.

The funding mechanism being used to support this program,
administrative supplements, can be used to cover cost increases that are
associated with achieving certain new research objectives, as long as the
research objectives are within the original scope of the project, or the cost
increases are for unanticipated expenses within the original scope of the
project. Any cost increases need to result from making modifications to the
project that would increase or preserve the overall impact of the project
consistent with its originally approved objectives and purposes.

Award Project Period

The project and budget periods must be within the
currently approved project period for the existing parent award.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

All organizations administering an eligible parent award may
apply for a supplement under this announcement.

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

This announcement is for supplements to existing projects.
To be eligible, the parent award must be active and the research proposed in
the supplement must be accomplished within the competitive segment. The
proposed supplement must be to provide for an increase in costs due to
unforeseen circumstances. All additional costs must be within the scope of the
peer reviewed and approved project.

IMPORTANT: The research proposed by the NIH grantee in the supplement
application must be within the original scope of the NIH-supported grant
project..

Current
NIH awardees with NIH grants pertinent to health outcomes of
women’s health and child survival from HAP may apply for an administrative
supplement provided the following conditions are met:

The topic of the administrative supplement must be related to the
focus of research or training proposed and conducted under the original NIH
award (parent award);

Efforts proposed and funds requested in the administrative
supplement application must expand on the original study design and be relevant
to women’s health and child health risks from HAP;

The parent award must remain active during the entire funding
period of this supplement; and

The Principal Investigator(s) for the supplement must be the
Principal Investigator(s) of the parent award.

Applicants are strongly encouraged to contact the
Scientific/Research Contact listed at the end of this FOA to discuss a potential
supplement application.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to
apply.

Applicant organizations must complete the following registrations
as described in the Application Guide to be eligible to apply for or receive an
award. Applicants must have a valid Dun and Bradstreet Universal Numbering
System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal
Investigator)

Individual(s) must hold an active grant or cooperative
agreement, and the research proposed in the supplement must be accomplished
within the competitive segment of the active award. Individuals are invited to
work with their organizations to develop applications for support.

For supplements to parent awards that include multiple PDs/PIs, the supplement
may be requested by any or all of the PD/PIs (in accordance with the existing
leadership plan) and submitted by the awardee institution of the parent award. Do
not use this administrative supplement application to add, delete, or change
the PD/PIs listed on the parent award. Visit the Multiple Program
Director/Principal Investigator Policy in the SF424 (R&R) Application Guide
for more information.

Applicant organizations may submit more than one
application, provided that each is sufficiently distinct from any other
administrative supplement currently under consideration by the awarding NIH Institute
or Center.

Since applications in response to this announcement will
only receive administrative review by the awarding Institute or Center, and
will not receive a peer review, the NIH policy on resubmissions will not apply.
However, applications not accepted by the Institute or Center for review, or
not funded by the Institute or Center, should not be submitted again without
either responding to any written concerns or contacting the awarding Institute
or Center for instructions first.

Section IV. Application and
Submission Information

1. Requesting an
Application Package

Applicants are required to prepare applications according to
the current application forms in accordance with the Application Guide.
For electronic submissions, applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this announcement, or use the eRA Commons streamlined
submission process.

2. Content and Form of Application Submission

All forms should be completed for the supplemental
activities only and should not reflect funding or activities for the
previously awarded parent award.

It is critical that applicants follow the instructions in the Application Guide
(SF424
(R&R) Application Guide or PHS398
Application Guide, as appropriate) except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

All page limitations described in the Application Guide and
the Table
of Page Limits must be followed.

The page limit for the Research Strategy section of the
administrative supplements submitted in response to this FOA is limited to six
pages.

Application Submission

The process for submitting an application varies depending
on whether the activity code of the parent award requires electronic submission
(as of the submission date of the supplement application). Visit the list of Activity
Codes Processed Electronically by eRA to determine if the activity code of
the parent award has transitioned to electronic submission.

If the parent award’s activity code has not transitioned to
electronic submission, then you must use the PHS398 Application Forms and
follow the PHS398 Application Guide.

If the parent award’s activity code has transitioned to
electronic submission, then you may either (A) electronically submit using the
SF424 (R&R) Application Forms and Grants.gov/Apply, (B) electronically
submit using the streamlined submission process of eRA Commons, or (C) submit
using the paper-based PHS398 Application forms and the PHS398 Application
Guide.

Instructions for Submissions using Grants.gov/Apply
for electronic-based submissions

For grants with activity
codes that have transitioned to electronic submission using the SF424
(R&R) application forms, administrative supplement requests may be
submitted electronically. Prepare applications using the SF424 (R&R)
application forms associated with this
announcement. Please note that some components marked optional in the
application package are required for submission of applications for this
announcement. Follow all instructions in the SF424 (R&R) Application Guide
to ensure you complete all appropriate required and optional components.

Special Instructions for Streamlined
Submissions using the eRA Commons for electronic-based submissions

NIH now offers a streamlined system through the eRA
Commons for submitting administrative supplements. Login to the eRA Commons,
identify the parent award, and prepare an administrative supplement request.

Include the Specific Aims, Research Strategy and
Cover Letter (described below) as a PDF file using the “Add Other Attachments”
function. Budget information should be entered for the grantee institution in
the fields provided. There is no template or form available for subaward
information; instead, all subaward information should be included as a separate
attachment showing the funds requested (by budget period) using the same
categories provided for the grantee institution. Also include a budget
justification for the subawardee institution in the same file.

Applications must be prepared using the PHS398
research grant application forms and instructions for preparing a research
grant application. The grantee institution, on behalf of the PD/PI of the parent
award, must submit the request for supplemental funds directly to the awarding
component that supports the parent award. Submit a signed, typewritten original
of the application, including the checklist, and two signed photocopies in one
package to:

On the face page of the application form, note that
your application is in response to a specific program announcement, and enter the
title and number of this announcement.

PHS398 Research Plan Component (Research Plan)

All instructions in the Application Guide must be followed
for all Research Plan sections applicable to the proposed supplement
activities. At a minimum, the Research Strategy section should be completed and
must include a summary or abstract of the funded parent award or project. Other
sections should also be included if they are being changed by the proposed
supplement activities.

Applicants
should include the following components of the Research Plan in the application
for the Administrative Supplement:

Specific Aims of the project submitted as an Administrative
Supplement (not to exceed one page). Discuss scope of the overall (parent)
project and contributions of the requested project to the goals and aims of the
parent.

Research Strategy of the project submitted as an Administrative
Supplement (not to exceed 6 pages' Within the Research Strategy, applicants
should address the following items:

Detailed
research or research training design, approach, methods and data analyses for
the proposed project.

Expected
outcomes and relationship to parent specific aims; and

Timeline
and milestones to be accomplished;

Cover Letter (for use with
electronic and paper-based applications)

Include acover Letter which cites this FOA and the
following:

Project Director/Principal Investigator (PD/PI) name

Parent grant number and title

Amount of the requested supplement

Name and title of the institutional official, and

Phone, email, and address information for both the PD/PI and
institutional official.

The cover letter must be signed by the authorized organizational
representative/institutional official.

PHS Form Page 1 Face page (for use with paper-based
applications)

The title of the project should be the title of the parent award.

This FOA should be cited in Box 2, and the “yes” box should be
checked.

The Program Director(s)/Principal Investigator(s) must be the
same as the PI on the parent award. For Multiple PI parent awards, the
Contact PI must be the PI listed on the supplement request, and the supplement
cannot change the Multiple PI team.

The remaining items on the face page should be filled out in
accordance with the PHS 398 application instructions.

PHS Form Page 2 (for use with
paper-based applications)

Note: The project “summary” is that of the administrative
supplement, not the parent grant.

Project/Performance Site Locations (Project/Performance
Sites)

Include the primary site where the proposed supplement
activities will be performed. If a portion of the proposed supplement activities
will be performed at any other site(s), identify the locations in the fields
provided.

Senior/Key Personnel Form

List the PD/PI as the first person (regardless of their role
on the supplement activities). List any other Senior/Key Personnel who are being
added through this supplement, or for whom additional funds are being requested
through this supplement; include a biographical sketch for each. Follow all
instructions in the Application Guide.

R&R Detailed Budget Form (for use with electronic
submissions)

All budgets should be submitted using the R&R Detailed
Budget form, regardless of the form used for the parent award, and should only
include funds requested for the additional supplement activities.

Budget for the Entire Proposed Period of Support (for use
with paper-based submissions)

A proposed budget should be submitted using the PHS398
budget forms, in accordance with the PHS398 Application Guide, and should only
include funds requested for the additional supplement activities.

If applicable, include documentation that the proposed research
experience was approved by the Institutional Animal Care and Use Committee
(IACUC) or human subjects Institutional Review Board (IRB) at the grantee
institution. Adherence to the NIH policy for including women and minorities in
clinical studies must also be ensured, if additional human subjects’
involvement is planned for the supplement component.

The filename provided for each “Other Attachment”
will be the name used for the bookmark in the electronic application in eRA
Commons.

Foreign Institutions

Foreign (non-US) institutions must follow policies described
in the NIH
Grants Policy Statement, and procedures for foreign institutions
described throughout the Application Guide.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications as described above. Applicants
must then complete the submission process by tracking the status of the
application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application in the eRA Commons to ensure
accurate and successful submission.

For electronic application submission, information on the
submission process and a definition of on-time submission are provided in the SF424(R&R)
Application Guide.

For paper-based application submission, iinformation on the process of receipt and determining if your application is considered
“on-time” is described in detail in the PHS398 Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:For applications submitted electronically on the SF424
(R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID
in the Credential fieldof the Senior/Key Person Profile Component of
the SF 424(R&R) Application Package. Failure to register in the
Commons and to include a valid PD/PI Commons ID in the credential field will
prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the Application Guide.

Upon receipt, applications will be evaluated for
completeness by the awarding Institute or Center. Applications that are
incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Not Applicable.

Section V. Application Review Information

1.
Criteria

Administrative Supplements do not receive peer review. Instead,
the administrative criteria described below will be considered in the administrative
evaluation process.

The staff of the NIH awarding component will evaluate
requests for a supplement to determine its overall merit. The following general
criteria will be used:

Budget and
Period of Support

NIH Staff will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

Overall Impact

NIH staff will consider the ability of the proposed
supplement activities to increase or preserve the parent award’s overall impact
within the original scope of award:

Will the administrative supplement increase or preserve the
likelihood for the project to exert a sustained, powerful influence on the
research field(s) involved?

Will the administrative supplement increase or preserve the
likelihood for the candidate to maintain a strong research program?

Will the administrative supplement increase or preserve the
likelihood for the program to exert a sustained, powerful influence on the
research field(s) involved?

Will the administrative supplement increase or preserve the
potential benefit of the instrument requested for the overall research
community and its potential impact on NIH-funded research?

Selection Factors

Administrative supplement requests will be reviewed at NIH
by Program and Grants Management Staff affiliated with the Institutes and
Centers funding the parent grant, in addition to other Institute, Center and
Office program staff with expertise related to the studies proposed.

Selection factors will include the following:

Relevance of the proposed research or training to the parent
grant;

Scientific merit of the proposed research or training;

Adequate progress of the parent grant appropriate to the current
state of the project;

Appropriate timelines to accomplish stated goals of the proposed
supplemental research or training activity.

Appropriateness of the research or training team members if
additional expertise is required within the proposed project.

In addition, each of the following criteria will be evaluated
as applicable for the proposed supplement.

Protections for Human Subjects:

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, NIH staff will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46, NIH
staff will evaluate: 1) the justification for the exemption, 2) human subjects
involvement and characteristics, and 3) sources of materials. For additional
information on review of the Human Subjects section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research,
NIH staff will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

NIH Staff will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary
care; 4) procedures for limiting discomfort, distress, pain and injury to that
which is unavoidable in the conduct of scientifically sound research including
the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable
restraining devices; and 5) methods of euthanasia and reason for selection if
not consistent with the AVMA Guidelines on Euthanasia. For additional
information on review of the Vertebrate Animals section, please refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

NIH Staff will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

2. Review and Selection
Process

Administrative supplement requests will undergo an
administrative evaluation by NIH staff, but not a full peer review. Applications
submitted for this funding opportunity will be assigned to the awarding
component for the parent award and will be administratively evaluated using the
criteria shown above.

3. Anticipated Announcement
and Award Dates

Not Applicable.

Section VI. Award
Administration Information

1. Award Notices

A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications.
This may be as an NoA for the supplemental activities only; alternatively, it
may be as either a revision to the current year NoA or included as part of a
future year NoA. The NoA signed by the grants management officer is the
authorizing document and will be sent via email to the grantee’s business
official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

Any supplements to Cooperative Agreements will be subject to
the same Cooperative Agreement terms and conditions as the parent award.

3. Reporting

Reporting requirements will be specified in the terms and
conditions of award as applicable to the supplemental activities. In most non-competing
continuation applications, the progress report and budget for the supplement
must be included with, but clearly delineated from, the progress report and
budget for the parent award. The progress report must include information about
the activities supported by the supplement even if support for future years is
not requested. This information is submitted with the PHS
Non-Competing Grant Progress Report, Form 2590, and financial statements as
required in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.